- Summary of MDR Regulation
- Changes Affecting the MDR Regulation (Federal Register final rule published on December 11, 1995)
- Federal Register Summaries
- Reporting Problems with Medical Devices
Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.
Summary of MDR Regulation
On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective for user facilities and device manufacturers. This document describes the current provisions for device manufacturers.
The MDR regulation provides a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. Although the requirements of the regulation can be enforced through legal sanctions authorized by the Federal Food Drug & Cosmetic (FD&C) Act, FDA relies on the goodwill and cooperation of all affected groups to accomplish the objectives of the regulation.
The statutory authority for the MDR regulation is section 519(a) of the FD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990. The SMDA requires user facilities to report:
- device-related deaths to the FDA and the device manufacturer;
- device-related serious injuries to the manufacturer, or to FDA if the manufacturer is not known; and
- submit to FDA on an annual basis a summary of all reports submitted during that period.
The SMDA requires FDA to issue regulations requiring distributors to report device-related deaths, serious injuries and reportable malfunctions. On September 1, 1993, FDA published a final MDR reporting regulation for distributors, including provisions for importers that became effective on October 1, 1993. In addition, the SMDA requires distributors and manufacturers to certify to FDA the number of MDR reports filed or that no reports have been filed.
The user facility reporting section of SMDA became effective on November 28, 1991. Device manufacturers should familiarize themselves with the user facility requirements and read the guidance document entitled, "Medical Device Reporting for User Facilities." Since 1984, domestic manufacturers have been subject to the MDR regulation if they were required to register their establishment with the FDA. The new MDR regulation eliminates this link with registration. All manufacturers of finished medical devices and components which are ready for use, including foreign manufacturers, are now subject to the requirements of the MDR regulation, despite registration status.
To carry out the reporting provisions of SMDA, FDA published a tentative final rule in the Federal Register (FR) on November 26, 1991, proposing to implement reporting regulations for users and distributors. In addition, the tentative final rule proposed to amend the existing 1984 MDR reporting regulation for manufacturers. On June 16, 1992, President Bush signed into law the Medical Device Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the FFD&C Act) that relate to the reporting of adverse events. The primary impact of the 1992 Amendments on MDR reporting was to define certain terms and to establish a single reporting standard for user facilities, manufacturers and distributors.
The final MDR regulation for user facilities and manufacturers, published in the Federal Register on December 11, 1995, addresses the comments received by FDA on the November 29, 1991, tentative final regulation and the changes mandated by the Amendments of 1992.
Significant changes for manufacturers from the 1984 MDR regulation include:
- different time frames for reporting
- use of standardized reporting forms
- removal of unanticipated temporary impairments
- new definitions
- addition of an FDA disclaimer
- removal of the "per se" rule
- requirement for foreign manufacturers to have a U.S. Designated Agent for reporting MDR events to FDA. (STAYED 7/23/96)
Changes Affecting the MDR Regulation (Federal Register final rule published on December 11, 1995)
The FDA began to receive comments regarding the regulation, following publication of the December 11, 1995, final rule on Medical Device Reporting for manufacturers and user facilities. The FDA staff subsequently met with industry representatives to discuss their concerns about the new regulation. Following these discussions, FDA decided to place all or portions of three specific parts of the regulation into abeyance. This means that FDA has revoked/stayed, or delayed these parts from going into effect.
- Foreign manufacturers are not required to have a U.S. Designated Agent;
- There is no requirement to submit distribution information dictated by sections 803.55(b)(9) and (10) of the baseline reporting requirement. This means that manufacturers do not fill out data elements 15 and 16 only of the baseline report (Form FDA 3417);
- A foreign manufacturer is fully subject to the medical devices reporting requirements. If a foreign manufacturer already has a USDA, they may forward medical device reports through this agent until further notice. However, if a foreign manufacturer chooses to employ a contact in the United States (U.S.) to forward reports to FDA, FDA views this person as if he or she is an employee of the foreign firm. The FDA explains these decisions in the Federal Register (FR) notices summarized below; and
- The FDA encourages foreign firms to register with FDA by completing a Form FDA 2891, "Initial Registration of Device Establishment."
Modernization Act Changes: Effective: February 19, 1998
Distributors of medical devices are no longer required to report device related adverse events involving death, serious injury and malfunction to the FDA and/or the device manufacturer. Instead, distributors must keep records of complaints and make the records available to FDA upon request.
- Annual Certification Requirement
Repeals the requirement for manufacturers, importers and distributors to submit an annual certification, Form FDA 3381, to FDA certifying whether any adverse event reports were filed during the previous year and, if so, the number filed.
- User Facilities
The user facility semi-annual reporting requirement has been changed to annual reporting. The annual report will now be due on January 1 of each year. User facilities may continue to use the current semi-annual user facility report form, FDA 3419, until a revised one is issued by FDA.
The identity of user facilities that are submitting MDR reports is protected from disclosure except in connection with:
- certain actions brought to enforce device requirements under the FFD&C Act; or
- a communication to a manufacturer of a device that is the subject of a report to FDA of death, serious illness or injury, or other significant adverse experience.
Federal Register Summaries
- 1st Notice, Federal Register, July 23, 1996: Stay of Effective Date; Revocation of Final Rule.
- 2nd Notice, Federal Register, July 23, 1996: Medical Device Reporting; Certification and U.S. Designated Agents (USDA); Proposed Rule.
- 3rd Notice, Federal Register, July 31, 1996: Baseline Reports, Stay of Effective Date.
- 4th Notice, Federal Register, March 20, 1997: Medical Device Reporting; Annual Certification; Final Rule.
1st Notice, Federal Register, July 23, 1996: Stay of Effective Date; Revocation of Final Rule
In this FR notice, the FDA changed the MDR requirements as follows:
- The effective date of the annual certification provision of the MDR regulation for manufacturers and distributors was stayed.
- Annual certification provisions for manufacturers were stayed to allow FDA to address industry concerns. The FDA reproposed this provision as described below.
- The existing requirement for distributors to annually certify was revoked (804.30). It was also reproposed, so that manufacturers and distributors would be treated the same regarding certification; and
- The U.S. designated agent requirements for foreign manufacturers were stayed (803.58).
In addition, foreign manufacturers, as of July 31, 1996, have a responsibility to comply with all remaining medical device reporting requirements. The original medical device reporting regulation that became effective on December 14, 1984, defined a manufacturer required to submit MDR reports, as any person FDA required to register under 21 CFR Part 807. Since foreign manufacturers are not required to register, the December 1984 regulation was not applied to them. The new medical device reporting regulation, published December 11, 1995, no longer defines a manufacturer as a person whom FDA requires to register under 21 CFR Part 807. Under section 803.3(n), a manufacturer is defined as any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure(s). Accordingly, foreign manufacturers fit within the new definition of manufacturers that FDA requires to submit MDR reports.
Therefore, as of July 31, 1996, all manufacturers, including foreign manufacturers, are subject to all requirements of 21 CFR Part 803 (Medical Device Reporting) including, but not limited to:
- the requirements for written MDR procedures (§803.17);
- MDR event files (§803.18);
- individual adverse event reports (§803.50 and §803.52);
- fiveday MDR reports (§803.53);
- MDR baseline reports (§803.55); and
- MDR supplemental reports (§803.56).
In addition, the regulations that are now in effect, and will remain in effect during the stay, permit foreign manufacturers to:
- register their companies using Form FDA 2891, "Medical Device Establishment Registration," [§807.40(a)], and
- submit premarket notifications [510(k)s] (§807.81).
These regulations also require foreign manufacturers to list their devices on Form FDA 2892, medical "Device Listing," [§807.40(b)]. (Refer to the "Reporting for Foreign Manufacturer" section for the correct version of §807.40.)
2nd Notice, Federal Register, July 23, 1996: Medical Device Reporting; Certification and U.S. Designated Agents (USDA); Proposed Rule.
In this FR notice, FDA reproposed the annual certification requirements for manufacturers and distributors. The proposed annual certification changes:
- eliminate the current certification statement;
- substitute a new certification statement that states that the certifying official has;
- read the MDR regulation,
- made certain that the manufacturer has established an MDR reporting system, and
- determined that a certain number of reports, or no reports, have been submitted.
- provide flexibility by allowing firms to identify the certifying agent for annual certification, rather than requiring the certifying agent to be the Chief Executive Officer or the President of the company.
A summary of the reporting requirements for manufacturers is provided in Table 1. Reporting requirements for user facilities and distributors are summarized in Table 2.